Device product
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Z-1295-2023
Product summary
- Firm
- Entopsis , Inc.
- Event
- Event 91723
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1295-2023
Official wording
Reason: Presence of misleading label statements on the product label.
Code information: Lot number 3, Exp. 11/2023
Distribution pattern: Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Derived failure modes
-
Unknown
Presence of misleading label statements on the product label.